FDA 510(k) Clears iTraumaCare™ iTClamp™ Hemorrhage Control System

iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has gained US FDA 510(k) clearance to market the iTClamp™ Hemorrhage Control System, in the United States.

The product, which was licensed for sale in Canada in late 2012 and received its CE Mark for sale in Europe in March 2013, will be available to medical professionals in the US within 30 to 45 days.

Background

Incorporated in 2010 and based in Edmonton, Canada with its global commercialization headquarters in San Antonio, Texas, iTraumaCare is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios.

The iTClamp™ frankly resembles a bulldog clip, but we’re guessing has to be more sophisticated than that. You get the picture though. The device has been designed to control severe bleeding in seconds. The iTClamp™ seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired.

Company comments

iTraumaCare’s CEO and founder, Dr. Dennis Filips, said, “With this regulatory milestone achieved, we look forward to putting the iTClamp in the hands of health care professionals in the United States and improving patient care.”